(83 days)
Not Found
No
The summary describes a purely mechanical device (threaded, hollow cylinder) made of PEEK and carbon fiber, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
No.
The device is a cement restrictor used in orthopedic surgeries, not designed to directly treat a disease or condition for therapeutic benefit.
No
The device is a cement restrictor used during orthopedic surgeries, not for diagnosing medical conditions.
No
The device description clearly states it is a "threaded, hollow cylinder that is manufactured from PEEK Optima LT1 with carbon fiber," indicating it is a physical hardware device, not software.
Based on the provided information, the Spine-Tech™ Cement Restrictor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for use in orthopedic surgeries as a cement restrictor in the femoral canal and tibial plateau. This is a surgical implant/accessory used in vivo (within the body) during a procedure.
- Device Description: The description details a physical, implantable device made of PEEK and carbon fiber, intended to be used with PMMA cement during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Spine-Tech™ Cement Restrictor does not perform any such function.
Therefore, the Spine-Tech™ Cement Restrictor is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Spine-Tech™ Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
The Spine-Tech™ Cement Restrictor is NOT intended for any spinal indications.
Product codes (comma separated list FDA assigned to the subject device)
JDK
Device Description
The Spine-Tech™ Cement Restrictor is a threaded, hollow cylinder that is manufactured from PEEK Optima LT1 with carbon fiber. This device is intended to be used in conjunction with PMMA cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral canal and tibial plateau
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
OCT 2 9 2002
Centerpulse, Spine-Tech Division
『
| (21 CFR Part 807.92) | |
|---|---|
| Submitter Information | |
| A. | |
| Submitter's Name: | Angela Byland |
| Address: | 7375 Bush Lake Road |
| Minneapolis, MN 55439-2027 | |
| Telephone Number: | (952) 857-5631 |
| Fax Number: | (952) 830-6388 |
| Contact Person: | Angela Byland |
| Date Submission Prepared: | August 6, 2002 |
| B. | |
| Device Information | |
| Trade Name: | |
| Common or Usual Name: | Spine-Tech™ Cement Restrictor |
| Canal Plug, Cement Restrictor | |
| Classification Name: | (per 21 CFR Part 878.3300) |
| Device Classification: | Class II (per 21 CFR Part 878.3300) |
| Panel -Orthopedic | |
| Predicate Device: | RPX TM Titanium Cement Restrictor Device (K020344) |
| Comparative Device: | Medtronic Sofamor Danek PEEK Optima™ LT Cement Restrictor |
| (K010528) | |
| Subject Device Description: | The Spine-Tech™ Cement Restrictor is a threaded, hollow |
| cylinder that is manufactured from PEEK Optima LT1 with carbon | |
| fiber. This device is intended to be used in conjunction with | |
| PMMA cement. | |
| Intended Use: | The Spine-Tech™ Cement Restrictor is intended for use as a |
| cement restrictor in orthopedic surgeries such as those involving | |
| the femoral canal and tibial plateau in hip stem and total knee | |
| replacement. | |
| The Spine-Tech™ Cement Restrictor is NOT intended for any | |
| spinal indications. |
510(k) Summary
C. Substantial Equivalence
The technological characteristics of the Spine-Tech™ Cement Restrictor Device are similar to the following predicate devices:
-
- RPX™ Titanium Cement Restrictor Device (K020344), manufactured by Centerpulse, Spine-Tech Division and cleared by the FDA on May 2, 2002.
-
- Medtronic Sofamor Danek Cement Restrictor PEEK Optima™ LT (K010528), manufactured by Medtronic Sofamor Danek and cleared by the FDA on October 10, 2001.
Establishment of equivalence is based on similarities of intended use, design, and physical characteristics.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2002
Ms. Angela Byland Senior Regulatory Affairs Specialist Centerpulseº - Spine-Tech Division 7375 Bush Lake Road Minneapolis, Minnesota 55439-2027
Re: K022615
Trade Name: Spine-Tech" Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: September 27, 2002 Received: September 30, 2002
Dear Ms. Byland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:
WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.
THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.
2
Page 2 - Ms. Angela Byland
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address: http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Daniel Schultz, M.D.
Daniel Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Spine-Tech™ Cement Restrictor
Indications for Use:
The Spine-Tech Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
PLEASE DO NOT WRITE BELOW THIS LINE---- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Mark N. Millman
(Division Sign-Off (Division Sign of General, Restorative Division ological Devices
510(k) Number K022615
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-the-Counter-Use (optional form at 1-2-96)